Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Precancerous Condition, Prostate Cancer
About this trial
This is an interventional prevention trial for Precancerous Condition focused on measuring prostate cancer, precancerous condition
Eligibility Criteria
INCLUSION CRITERIA: Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate) EXCLUSION CRITERIA: Definitive invasive prostate cancer on initial biopsy Significant active medical illness that in the opinion of the clinician would preclude protocol treatment. History of ventricular tachycardia or ventricular fibrillation Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial. Subject reported allergy or sensitivity to fish oil, olive oil or green tea Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated. Total bilirubin greater than institutional upper limit of normal Concurrent high risk study participation
Sites / Locations
- Kaiser Permanente Center for Health Research
- OHSU Knight Cancer Institute
- Veterans Affairs Medical Center - Portland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Arm I (FO, GT catechin extract)
ArmII (FO placebo, GT catechin extract)
Arm III (FO, GT placebo)
Arm IV (FO placebo, GT placebo)
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day